Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05614323 |
| Other study ID # |
202200345 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 16, 2022 |
| Est. completion date |
March 2024 |
Study information
| Verified date |
June 2023 |
| Source |
University Medical Center Groningen |
| Contact |
Jacco J de Haan, MD, PhD |
| Phone |
+31 50 361 2821 |
| Email |
j.j.de.haan[@]umcg.nl |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
In hospitalized patients with cancer treated with systemic therapy, semi-structured in-depth
interviews will be performed. Topics that will be discussed are eating-related complaints,
the taste and smell of the offered hospital food, the choice in hospital food, the ambience
during the eating moments, the use of protein-enriched snacks, the difference between eating
at home and at the hospital, and personal tips-and-tricks to maintain adequate nutritional
intake and improve food enjoyment in the hospital. Patients will be included until data
saturation is reached. The interviews will be recorded and analyzed according to the
principles of thematic analysis.
Description:
This qualitative study will be performed in all patients with cancer admitted to the
Comprehensive Cancer Center (CCC) wards in the UMCG: medical oncology (D2) and hematology
(E2). Potential participants are identified by the medical oncologists and dietitians who are
part of the study team. Patients with pathologically confirmed diagnosis of all-types of
cancer, treated with systemic therapy will be included. These patients are contacted during
their hospital stay by their treating physician or nurse. They will introduce the study to
the patient and will ask the patient permission for a visit by the investigators. The
investigators will, when permission has been given, visit the patient and inform the patient
about the study. Patients have to be hospitalized more than two days, as they will then have
had multiple meals in a hospital environment.
Potential participants are given verbal information about the study and, if they are
interested, also written study information. The potential participants are contacted by the
investigators three days later for written informed consent, and setting a date for the
interview, possibly during hospitalization.
At the agreed date, first, the Patient-Generated Subjective Global Assessment (PG-SGA) Short
Form will be filled in by the participants. This questionnaire consists of four questions
regarding weight, food intake, symptoms and activities/function. Next, a semi-structured
in-depth interview will be performed in a quiet environment. The interview will take a
maximum of one hour and will take place once. Topics that will be discussed are
eating-related problems, the taste and smell of the offered hospital food, the choice in
hospital food, the ambience during the eating moments, the use of protein-enriched snacks,
the difference between eating at home and at the hospital, personal tips-and-tricks to
maintain adequate nutritional intake, and how patients' think that food enjoyment can be
improved in the hospital. The interview will be recorded. At last, taste and smell will be
objectively determined with respectively taste strips and Sniffin' Sticks. Taste strips with
an impregnated taste solution will be placed in the participants' mouth. The taste solutions
contain the basic tastes bitter, sweet, sour and salty in four different concentrations, thus
16 tests will be performed. The strips will randomly be administered and participants are
asked which taste they notice. A right answer gives one point and a total of 16 point can be
obtained. Sniffin' Sticks are pens filled with liquid odorants, which are presented to the
participants' nose. Participants will smell 16 different scents with an interval of minimal
30 seconds to prevent desensitization. For each scent, participants will choose between four
options from a multiple choice card.
At last, the participants will be asked if topics were missed and if questions or topics were
clear and are asked if they can be contacted for future studies. After the conversation, the
background of the participant will be collected from the patients electronic file, including
stage and location of primary tumor, type and status of treatment, duration of treatment,
age, gender, days of hospitalization, current diet (including tube feeding and drink
feeding), weight (loss), and medical history affecting taste, smell or mouthfeel.
Participants will be included until data saturation is reached, i.e., no new insights or
themes are reported by the participants (15-20 participants). By purposive sampling, a varied
group of participants will be included. Patients are excluded if contra-indication for oral
food intake exist or oral food intake is perceived as painful by the patient. The interviews
will be audio recorded, transcribed verbatim, and analyzed according to the principles of
thematic analysis, with Atlas-ti. The audio recordings will be saved on the Research Drive of
the UMCG and will be destroyed after transcribing. The baseline characteristics will be saved
in REDCap (Research Electronic Data Capture, Version 10.0.23), an application to support data
capture in a safe web-based environment, hosted by the UMCG.
